Introducing ISO 7101: A global standard for high-quality healthcare
The birth of a global standard
In 2018, several influential publications from WHO, OECD, and The Lancet highlighted the need for high-quality healthcare, especially in low and middle-income countries. At the same time, technical experts identified the need for a framework based on the tried-and-true ISO management systems approach in the healthcare sector. Based on the gaps identified, Technical Committee 304 for Healthcare Organization Management created an expert work group committed to addressing this important need, while aiming to enhance global health systems, health outcomes and patient safety.
The collaborative effort
The working group, comprised of doctors, nurses, risk managers, academics, and consultants, worked together to create a standard that transcends national agendas. Professor Adam Layland, the former 304 Technical Committee Chair and work group Convenor, played a crucial role in guiding through complex discussions to build consensus. This standard reflects a collective dedication to improving global healthcare. Professor Layland reinforced the nature of the international consensus approach sharing, “Our philosophy throughout the development of the standard has been, For the world, by the world.”
Addressing global healthcare challenges
Healthcare systems worldwide face increasing demands, decreased funding, and workforce shortages. ISO 7101 offers a structured system to improve patient care and workforce wellbeing, applicable to healthcare organizations of all sizes and types. It emphasizes continual quality improvement, effective leadership, risk management, and comprehensive information management.
Key benefits of ISO 7101
- Improved service user experience: Enhances patient safety and outcomes, with a focus on the improved experience of patients, families and caregiver. The standard encourages co-design of patient care delivery.
- Enhanced organizational reputation: Improves reputation, aiding in workforce recruitment, while showing a public commitment to the highest standards of quality.
- Improved employee engagement: Focuses on people and their professional development, aiding in workforce retention, continuity of care, and loyalty towards the organization.
- Regulatory alignment: Aligns with standards like the Care Quality Commission's metrics, aiding compliance.
- Operational efficiency: Reduces bureaucracy, focuses resource utilization, and streamlines service delivery, positioning organizations for additional funding and research opportunities.
Applicable to organizations at each stage of their quality journey
- Emerging: Provides a clear starting point for establishing quality management systems
- Developing: Helps identify improvement opportunities through gap analysis and feedback mechanisms
- Mature: Allows established organizations to refine their systems and identify new improvement areas.
Continual improvement with the PDSA cycle
The Plan-Do-Study-Act (PDSA) cycle is central to ISO 7101, encouraging continual quality improvement through:
- Plan: Develop controlled, detailed processes while identifying resources needs.
- Do: Implement the plans.
- Study: Assess effectiveness and learn.
- Act: Make necessary adjustments and continue the cycle.
Effective implementation tips
- Understand the standard: Familiarize yourself with the ten clauses of ISO 7101.
- Engage leadership: Ensure leadership drives the quality agenda.
- Communicate clearly: Spread the quality goals and indicators across the organization.
- Document processes: Maintain detailed documentation to track progress.
- Focus on people: Prioritize inclusivity, diversity, coproduction and wellbeing.
Conclusion
ISO 7101 outlines requirements for organizations that strive to deliver safe, timely, efficient, effective, equitable and people-centred care. With its strong focus on leadership, organizations can enhance the service user experience, operational efficiency, and foster a culture of quality and safety. The successful implementation of ISO 7101 hinges on education and collaboration, ensuring organizations understand and correctly apply the standard. This effort, supported by BSI and global organizations like the World Health Organization (WHO), aims to enhance patient care and drive better organizational performance through resilient systems.
